Traditional manual suturing methods are slow; each hand-made stitch takes about 30-45 seconds. To enhance speed of wound closure, surgeons opt for staplers, which require about 3-5 seconds per stitch. Of all competing wound closure products, the most relevant competitor to the traditional needle and suture is the conventional surgical metal skin stapler, since seals, glues, and adhesive bandages are not suitable for deep, bloody wounds.
Although 6-15 times faster than traditional suturing, metal staples increase risk of infection by a factor of 4, requiring more most-operative visits and increased costs due to wound complications. Skin staples also leave unsightly railroad scarring due to the thickness and rigidity of stainless steel staples. Surgical stapling ultimately presents a 14 times greater risk of wound morbidity at discharge compared to suture closure. The only advantage of stapling is speed of wound closure.
The present invention aims to satisfy the need for rapid wound closure by matching the speed of the surgical stapler at 3-5 seconds per stitch. Furthermore, by utilizing traditional suturing needles and thread, the present invention aims to eliminate the risk of wound morbidity presented by metal staples.
A number of methods/products for wound closure that do not employ sutures include skin staplers, butterfly bandages, etc. These products are not relevant to our suturing device because they do not employ sutures, often the best way of closing large lacerations.
In U.S. Pat. Nos. 4,236,470 and 8,551,122, Stenson and Lau respectively teach a device that transfers a thread-holding needle between two prongs connected by a hinge in order to pass a thread from one side of a wound to another, forming a continuous suture. Stenson's device acts as a longer hand to be used in internal endoscopic procedures where the human hand cannot reach to manually make sutures. Stenson and Lau's inventions pierce the skin with a needle and drags suture material through the skin but do not make a complete suture as they do not attempt to tie off the thread. In fact, Stenson and Lau's inventions require more time than hand-made sutures and fail to complete the suturing process.
In essence, the prior art that intends to close wounds through sutures lacks either safety considerations for the user, features that allow use by those unskilled in the art of suturing, mechanisms to secure the suture, which is by far the most time-consuming component, and a mechanism that brings the edges of the wound together without the use of an additional device.
The current invention does not resemble other prior art that are considered “automatic” suturing devices because the current invention does not transfer a needle from one arm to another. Furthermore, the present invention may operate by first bringing the edges of the wound together using blunt-ended tissue prongs, eliminating the need for additional devices to assist in suturing and allow for suturing with one hand. The present invention automates the manual suturing process by pushing a needle and attached suturing material through the tissue, and securing the suture with an anchor located on the other arm of the device while reverting the arms back to their initial positions to reset the device in preparation for the next single interrupted suture.